Biotherapy Services Limited

Biotherapy Services Limited (BTS) is a United Kingdom-based biotherapy company focused on autologous biological therapies for wound healing and tissue regeneration. According to its official website, the company describes itself as a multidisciplinary team of clinicians, scientists, pharmacists and healthcare professionals dedicated to delivering safe and effective autologous biotherapies across a range of clinical applications. Its particular focus is wound healing and tissue regeneration, using blood-derived products rich in white blood cells and platelets that harness the body's own healing properties. The company states that it relies on state-of-the-art technology and patented proprietary processes, working to GMP pharmaceutical manufacturing standards. The company's lead offering is the RAPID™ Biodynamic Haematogel, a wound treatment under development for the management of complex and slow-healing wounds such as diabetic foot ulcers and pressure sores. The product is made up of concentrated platelets derived from the patient's own blood, which are activated by autologous thrombin to release healing growth factors, cell signalling molecules and proteins that work at a cellular level. Biotherapy Services states that its RAPID™ Biodynamic Haematogel wound care treatment has been defined by the MHRA as the first-in-world, first-in-class point-of-care wound care treatment classified as a medicine. Regulatory progress has been central to the company's development. In August 2018, Biotherapy Services was awarded an MIA:IMP licence by the Medicines & Healthcare products Regulatory Agency (MHRA) in recognition of the RAPID1-DFU trial, and at the same time the MHRA awarded the company a Specials (MS) licence for the manufacture of unlicensed medicines. On 8 November 2018, the MHRA and the Research Ethics Committee gave approval to commence the RAPID-1DFU Clinical Trial. Because RAPID Gel is an investigational medicinal product in a Stage 2b development phase, its application is limited within the scope of the clinical trial; however, the company notes that due to the high unmet clinical need surrounding chronic wounds, the MHRA recognised the potential of RAPID Gel and approved its use as a response to an unsolicited order. Biotherapy Services is headquartered in London, United Kingdom, and operates primarily in the UK market. It is a private company and does not appear to be listed on a public stock exchange. Its activities sit at the intersection of regenerative medicine, autologous cell and blood-derived therapies, and advanced wound care, a field where chronic wounds such as diabetic foot ulcers represent a significant and growing clinical burden.

Biotherapy Services Limited (BTS) is a United Kingdom-based biotherapy company headquartered in London. It describes itself as a multidisciplinary team of clinicians, scientists, pharmacists and healthcare professionals focused on the delivery of safe and effective autologous biotherapies for a range of clinical applications, with a particular focus on wound healing and tissue regeneration. The company uses blood-derived products rich in white blood cells and platelets that harness the healing properties of the body, and states that it relies on state-of-the-art technology and patented proprietary processes, working to GMP pharmaceutical manufacturing standards. The company's development has centred on its lead product, the RAPID™ Biodynamic Haematogel, a wound treatment for complex and slow-healing wounds such as diabetic foot ulcers and pressure sores. The product consists of concentrated platelets derived from the patient's own blood, activated by autologous thrombin to release healing growth factors, cell signalling molecules and proteins that work at a cellular level. Biotherapy Services states that the MHRA has defined its RAPID™ Biodynamic Haematogel wound care treatment as the first-in-world, first-in-class point-of-care wound care treatment classified as a medicine. A key period in the company's regulatory history came in 2018. Over the course of August 2018, Biotherapy Services Ltd. was awarded an MIA:IMP licence by the Medicines & Healthcare products Regulatory Agency (MHRA) as a recognition of the RAPID1-DFU trial. At the same time, the MHRA also awarded BTS a Specials (MS) licence for the manufacture of unlicensed medicines. The company describes the MIA:IMP licence as the stamp of approval for clinical trials conducted in the UK, which require ethical approval and authorisation from the MHRA, with an additional layer of control for investigational medicinal products (IMP) to ensure trials are conducted to Good Clinical Practices (GCP) throughout the entire process. The manufacture and import of IMPs is detailed in EudraLex Vol. 4 (Good Manufacturing Practice guidelines) and EudraLex Vol. 10 (Clinical Trial guidelines). On 8 November 2018, the MHRA and the Research Ethics Committee (REC) gave BTS approval to commence the RAPID-1DFU Clinical Trial. Because RAPID Gel is an investigational medicinal product in a Stage 2b development phase, its application is limited within the scope of the clinical trial. However, the company notes that due to the high, unmet "special" clinical need surrounding chronic wounds, the MHRA recognised the potential of RAPID Gel and therefore approved its use as a response to an unsolicited order. Under the Specials (MS) licence, unless exempt, a medicinal product must be the subject of a marketing authorisation or product licence before being placed on the market, with Regulation 167 of the Human Medicines Regulations 2012 providing an exemption. Biotherapy Services is a private company and does not appear to be listed on a public stock exchange. Its activities sit at the intersection of regenerative medicine, autologous cell and blood-derived therapies, and advanced wound care. The company's focus on chronic wounds addresses a clinical area with significant unmet need, particularly as conditions such as diabetic foot ulcers and pressure sores impose a substantial burden on patients and healthcare systems.

• Biotherapy Services Ltd. awarded an MIA:IMP licence by the MHRA in recognition of the RAPID1-DFU trial, and a Specials (MS) licence for the manufacture of unlicensed medicines.

• The MHRA and the Research Ethics Committee gave approval to commence the RAPID-1DFU Clinical Trial.

Clinical-stage developer of autologous, point-of-care biotherapies for complex and chronic wounds, operating to GMP pharmaceutical manufacturing standards.

• RAPID™ Biodynamic Haematogel

  An autologous wound treatment under development for complex and slow-healing wounds such as diabetic foot ulcers and pressure sores. It is made up of concentrated platelets derived from the patient's own blood, activated by autologous thrombin to release healing growth factors, cell signalling molecules and proteins that work at a cellular level. The MHRA has defined it as the first-in-world, first-in-class point-of-care wound care treatment classified as a medicine.

1. 1Biotherapy Services | Clinical therapies for tissue regenerationbiotherapyservices.com
2. 2Biotherapy Services | Servicesbiotherapyservices.com
3. 3Biotherapy Services Limited (United Kingdom) - Wikidatawikidata.org